BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2474225 · Received February 28, 2012

    Report

    Report Number
    1519132-2012-00014
    Event Type
    Other
    Date Received
    February 28, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 2, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSP OF THE INSTRUMENT CONFIRMS THAT THE CERAMIC TIP IS BROKEN OFF THE SHEATH TUBE. THE BROKEN PIECE OF CERAMIC WAS RETURNED WITH THE UNIT. A BURN IS NOTED ON THE BROKEN PIECE OF CERAMIC. THE BALANCE OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. ALSO NOTED ARE MULTIPLE DENTS ALONG THE STEEL TUBE. THE EXACT CAUSE OF THE BREAKAGE OF THE CERAMIC TIP CANNOT BE DETERMINED. DUE TO THE PRESENCE OF THE BURN IN THE PIECE OF THE CERAMIC TIP THAT WAS RETURNED AND THE DENTS/DAMAGE ON THE STEEL TUBE AND THE FACT THAT THE ADHESIVE ON THE BASE OF THE TIP HAS RETAINED THE PROXIMAL PORTION IN THE TUBE, THE CAUSE OF THIS FAILURE IS DETERMINED TO BE CAUSED BY THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE CERAMIC TIP OF THE RESECTOSCOPE INNER SHEATH FRACTURED AND BROKE INSIDE THE PT. ALL PIECES WERE RETRIEVED. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING CF RESECTOSCOPE INNER SHEATH FESECTOSCOPE INNER SHEATH FDC GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1